Healthy
Conditions
Keywords
Factor D Inhibitor, Complement, Bioavailability, Tablet, Capsule
Brief summary
This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.
Interventions
DRUGACH-0145228: Immediate Release
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
DRUGACH-0145228: Powder-in-capsule
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
Sponsors
Alexion Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
This will be a 3-sequence, 3-period crossover study in healthy adult participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening. 2. No clinically significant history or presence of electrocardiogram findings at screening. 3. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception. 4. Female participants must be of non-childbearing potential and need not employ a method of contraception.
Exclusion criteria
1. Clinically significant laboratory abnormalities. 2. History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study. 3. History or presence of drug or alcohol abuse within previous 2 years, current tobacco user, and positive drugs-of-abuse screen and alcohol screen at screening or Day -1 of Period 1. 4. History or presence of clinically significant seizures, head injury, or head trauma. 5. History of procedures that could alter absorption or excretion of orally administered drugs. 6. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection. 7. A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs. 8. Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing. 9. Is a female of childbearing potential. 10. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, and receipt of blood products within 6 months prior to first dosing. 11. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule | Up to 72 hours postdose | Relative bioavailability will be measured by the ratio of the area under the concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf). |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-inf Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions | Up to 72 hours postdose |
| Maximum Observed Concentration (Cmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions | Up to 72 hours postdose |
| Time To Maximum Observed Concentration (Tmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions | Up to 72 hours postdose |
| AUC0-t Of ACH-0145228 Powder-in-capsule Under Fasted Conditions | Up to 72 hours postdose |
| Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions | Up to 72 hours postdose |
| Cmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions | Up to 72 hours postdose |
| Tmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions | Up to 72 hours postdose |
| Number Of Participants With Treatment-emergent Adverse Events | Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration) |
| AUC0-inf Of ACH-0145228 Powder-in-capsule Under Fasted Conditions | Up to 72 hours postdose |
Countries
United States
Outcome results
None listed